The Eplontersen Pregnancy and Lactation Outcomes Study (EPPRO): A Descriptive Safety Study of Pregnant and Lactating Individuals and Their Offspring Exposed to Eplontersen
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
The overall objective of this DPSS is to describe the occurrence of pregnancy and maternal complications, adverse effects on the developing fetus and neonate, and adverse effects on the infant associated with exposure to eplontersen during pregnancy and/or lactation.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• all pregnancy and/or lactation cases with exposure to eplontersen and a diagnosis of an approved indication for treatment with eplontersen
• all adverse event reports in infants in the first 12 months of age that are or can be linked to pregnancy or lactation reports in individuals previously diagnosed with an approved indication and exposed to eplontersen during pregnancy or lactaction
Locations
Other Locations
Germany
Research Site
RECRUITING
Frankfurt
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-11-30
Estimated Completion Date: 2035-12-30
Participants
Target number of participants: 10
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: ICON plc